IRB Advisor: What positive results and/or drawbacks do you predict as your IRB returns to more normal levels of study review activity after the pandemic?
McGee: We all have tried to support each other. I believe that we may not ever go back to the way it had been. It will be a while before that could occur.
Doksum: Instead of preparing for normal levels of study review activity, we are adapting to a new normal of more time-sensitive review requests. For example, we are getting a lot of amendment requests related to our evaluations of government programs to assess the effects of the pandemic on outcomes related to education, employment, health, food security, and housing. Overall, the Abt IRB is responding to the pandemic by ensuring we keep up with evolving best practices to protect human subjects.
Reuter: IRB managers stayed in close touch with the members and staff to make sure they were OK. Some were dealing with illness in their own families, and support was given as needed. Most importantly, each IRB staff member was encouraged to communicate if they were feeling overwhelmed or burdened so they could receive whatever help they needed. Overall, the members and staff have handled this crisis at a level of excellence, and the BRANY IRB functions have continued without interruption. We have learned a lot about the resilience of our IRB members and staff to cope in the face of crisis. As we move toward the post-pandemic phase of COVID-19 recovery, we will come back together with a newfound appreciation of the need for ongoing communication, the willingness to extend ourselves beyond our normal job roles when needed, and the value of community, which I believe most of us took for granted before we were forced to socially distance from each other. I look forward to the post-pandemic phase, and am confident BRANY IRB will emerge stronger than ever.
Williams: The positive result of this is that we’ve all learned to be more flexible, and hopefully kinder, to one another in our work. At times, the stress levels are intense, and flexibility makes a huge big difference to individuals’ daily lives. In contrast, one significant drawback has been a decrease in research by both faculty and students. In addition, planned upgrades to our homegrown IRB systems have been shelved because of staffing issues and institutional priorities.
Moore: I think the longer we stay in a work-from-home situation, the more difficult it will be to return, especially with other commitments and responsibilities such as child care, when not all other industries may be reopened yet.
Rigtrup: IRB submissions and overall workload increased tremendously with the influx of amendments to existing studies and new study applications related to COVID-19. We made sure to check in often with everyone regarding their workload and our expectations for their productivity. We encouraged staff to take time off whenever they were able, even if only for a brief “mental health staycation,” and we checked in with each other just to see how everyone was doing. We were flexible with work schedules when staff needed to take care of children and family members. Most importantly, as layoffs and unemployment spread across the nation, we assured our staff as soon as we had confirmation that their employment and benefits were secure. We repeated this assurance each time social distancing protocols were extended.
I’m hopeful that as our IRB moves through these challenging times, our staff will have retained an increased sense of camaraderie, having come through an unprecedented and sometimes frightening time together as a team.
Smith: In the meantime, we’re finding out just how much of this work can be done via email and call-forwarding. We are not returning to the same old routine, so that’s a positive (aside from my emails at 6 a.m.). Beyond that, we’re not looking at the light at the end of the tunnel for clinical or in-person research just yet. I have my eyes on August for that, at the earliest — except for clinical treatment studies.
Newlin: One benefit is that because of the extra attention to COVID-19 research at an institutional level, everyone has seen the benefits of building quality into protocols early in the process and making sure sites have the resources and funding to perform the research. This extra attention has been useful for the IRB, as we spend less time reviewing protocols that don’t have that quality built in.
The drawbacks of the next stage are all around uncertainty — about levels of work, where we’ll be working, and the consequences of the pandemic generally. This stage has been a lot of critical work, with folks getting COVID treatment trials up and running very quickly. It has been a very meaningful time to work at an IRB. It’s unclear to me how the next phase will play out. If there is a second spike, IRBs could be bombarded again, or if there is a slow simmer, it could be a return to half-normalcy. No one knows for sure, and dealing with that uncertainty will be an ongoing challenge.
IRB experts share the ways in which the pandemic has spurred innovation in their institutions.
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